Azacitidine in Treating Patients With Chronic Myelomonocytic Leukemia

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RATIONALE: Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase II trial is studying the side effects of azacitidine and to see how well it works in treating patients with chronic myelomonocytic leukemia.

Detailed Description

OBJECTIVES:

Primary

To assess the safety and tolerability of azacitidine in patients with chronic myelomonocytic leukemia (CMML).

To assess the overall response rate in these patients.

Secondary

To assess the incidence of clinical remission/complete remission or partial response in these patients.

To assess hematological improvement in patients treated with this drug.

To assess the overall survival of patients treated with this drug.

To assess progression-free survival of patients treated with this drug.

To assess the time to acute myeloid leukemia (AML) transformation of CMML.

To assess the time to death or AML transformation of CMML.

To assess the biological correlates.

OUTLINE: This is a multicenter study.

Patients receive azacitidine subcutaneously on days 1-5 and 8-9. Treatment repeats every 4 weeks for at least 6 courses in the absence of loss of response/disease progression or unacceptable toxicity. Patients undergo response evaluation after 6 courses or the last course of treatment. Responders may continue azacitidine until loss of response/disease progression or unacceptable toxicity.